BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME INTERNATIONAL

    MDR report key: 5930332 · Received September 6, 2016

    Report

    Report Number
    1045254-2016-00291
    Event Type
    Malfunction
    Date Received
    September 6, 2016
    Date of Event
    August 8, 2016
    Report Date
    August 8, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 8253200: PATIENT INTERFACE RESPONSE 3.0, SERIAL # (B)(4), LOT # 205745800, MANUFACTURED DATE -MAR/01/2012, 510(K) # K083124. THE PRODUCTS NIM MAINFRAME (MODEL # 8253001) AND NIM PATIENT INTERFACE (MODEL # 8253200) WERE RETURNED FOR ANALYSIS. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8220325 - NIM MUTING PROBE, LOT AND MANUFACTURING DATE UNKNOWN. DATE MFR. REC: (B)(6) 2016. THE NIM MAINFRAME (PART # 8253002), NIM PATIENT INTERFACE (PART # 8253200) AND MUTING PROBE (PART # 8220325) WAS RETURNED FOR EVALUATION. EVALUATION OF THE NIM MAINFRAME (PART # 8253002) INDICATED THAT THE DEVICE FAILED THE COMMON MODE REJECTION TEST. THE MAIN PCB ON THE DEVICE FAILED. THE DEVICE WAS REPAIRED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. EVALUATION OF PATIENT INTERFACE (PART # 8253200) FOUND NO FAULT WITH THE DEVICE. EVALUATION OF THE NIM MUTING PROBE(PART # 8220325) FOUND A DAMAGED FERRITE AND AN O-RING MISSING. THE DEVICE WAS DAMAGED BEYOND REPAIR. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOX CONNECTED TO THE PROBE IS NOT WORKING. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581612 NIM® 3.0 MAINFRAME INTERNATIONAL STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253002 205784243

    Patients

    Seq Age Sex Outcome Treatment
    1